Syringe LL, W/BioCare Safety Needle BIO-1063S

GUDID 20858835007176

Disposable 5cc Syringe LL, W/BioCare Safety Needle 22G x 1 1/2", Each

BIOTRONIX HEALTHCARE INDUSTRIES, INC.

General-purpose syringe, single-use
Primary Device ID20858835007176
NIH Device Record Keyc44dc03c-4205-4603-9592-94545a353537
Commercial Distribution StatusIn Commercial Distribution
Brand NameSyringe LL, W/BioCare Safety Needle
Version Model NumberBIO-1063S
Catalog NumberBIO-1063S
Company DUNS065762392
Company NameBIOTRONIX HEALTHCARE INDUSTRIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100858835007172 [Primary]
GS110858835007179 [Package]
Contains: 00858835007172
Package: Inner Box [100 Units]
In Commercial Distribution
GS120858835007176 [Package]
Contains: 10858835007179
Package: Case [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMINeedle, Hypodermic, Single Lumen

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-12-24
Device Publish Date2019-10-08

On-Brand Devices [Syringe LL, W/BioCare Safety Needle]

00858835007127Disposable 3cc Syringe LL, W/BioCare Safety Needle 21G x 1 1/2", Each
20858835007749Disposable 5cc Syringe LL, W/BioCare Safety Needle 21G x 1 1/2"
20858835007435Disposable 10cc Syringe LL, W/BioCare Safety Needle 21G x 1 1/2"
20858835007176Disposable 5cc Syringe LL, W/BioCare Safety Needle 22G x 1 1/2", Each
20858835007152Disposable 3cc Syringe LL, W/BioCare Safety Needle 23G x 1"
20858835007145Disposable 3cc Syringe LL, W/BioCare Safety Needle 22G x 1 1/2"
20858835007138Disposable 3cc Syringe LL, W/BioCare Safety Needle 22G x 1"
20858835007107Disposable 3cc Syringe LL, W/BioCare Safety Needle 21G x 1"

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